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Prescribing Information HIGHLIGHTS OF PRESCRIBING INFORMATION ___________________ CONTRAINDICATIONS ___________________ These highlights do not include all the information needed to use Known hypersensitivity to aripiprazole (4) ARISTADA® safely and effectively. See full prescribing information for ARISTADA®. _______________ WARNINGS AND PRECAUTIONS _______________ • Cerebrovascular Adverse Reactions in Elderly Patients with Dementia- ARISTADA® (aripiprazole lauroxil) extended-release injectable Related Psychosis: Increased incidence of cerebrovascular adverse suspension, for intramuscular use reactions (e.g., stroke, transient ischemia attack, including fatalities) Initial U.S. Approval: 2015 (5.2). • Potential for Dosing and Medication Errors: Substitution and WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS dispensing errors between ARISTADA and ARISTADA INITIO could WITH DEMENTIA-RELATED PSYCHOSIS occur. Do not substitute ARISTADA INITIO for ARISTADA (5.3). See full prescribing information for complete boxed warning. • Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring (5.4). • Elderly patients with dementia-related psychosis treated with • Tardive Dyskinesia: Discontinue if clinically appropriate (5.5). antipsychotic drugs are at an increased risk of death. (5.1) • Metabolic Changes: Monitor for hyperglycemia, dyslipidemia, and • ARISTADA is not approved for the treatment of patients with weight gain (5.6). dementia-related psychosis. (5.1) • Pathological Gambling and Other Compulsive Behaviors: Consider dose reduction or discontinuation (5.7). __________________ _________________ INDICATIONS AND USAGE • Orthostatic Hypotension: Monitor heart rate and blood pressure and ARISTADA is an atypical antipsychotic indicated for the treatment of warn patients with known cardiovascular or cerebrovascular disease, and schizophrenia in adults (1). risk of dehydration or syncope (5.8). • Leukopenia, Neutropenia, and Agranulocytosis: Perform complete _______________ ______________ DOSAGE AND ADMINISTRATION blood counts in patients with a history of a clinically significant low • Administer ARISTADA by intramuscular injection in the deltoid (441 white blood cell (WBC) count. Consider discontinuation if clinically mg dose only) or gluteal (441 mg, 662 mg, 882 mg or 1064 mg) muscle significant decline in WBC in the absence of other causative factors by a healthcare professional (2.1). (5.10). • For patients naïve to aripiprazole, establish tolerability with oral • Seizures: Use cautiously in patients with a history of seizures or with aripiprazole prior to initiating treatment with ARISTADA (2.1). conditions that lower the seizure threshold (5.11). • There are two options for initiating treatment with ARISTADA: • Potential for Cognitive and Motor Impairment: Use caution when . Option #1: Administer one injection of 675 mg of ARISTADA operating machinery (5.12). INITIO® and one 30 mg dose of oral aripiprazole in conjunction with the first ARISTADA injection. (2.1). ___________________ ADVERSE REACTIONS ___________________ . Option #2: Administer 21 consecutive days of oral aripiprazole in Most commonly observed adverse reaction with ARISTADA (incidence ≥5% conjunction with the first ARISTADA injection (2.1). and at least twice that for placebo) was akathisia (6.1). • ARISTADA can be initiated at a dose of 441 mg, 662 mg or 882 mg administered monthly, 882 mg dose every 6 weeks, or 1064 mg dose To report SUSPECTED ADVERSE REACTIONS, contact Alkermes, every 2 months (2.1). Inc. at 1-866-274-7823 or FDA at 1-800-FDA-1088 or • Dosing regimen adjustments may be required for missed doses (2.2). www.fda.gov/medwatch. • Dose adjustments are required for 1) known CYP2D6 poor metabolizers and 2) for patients taking CYP3A4 inhibitors, CYP2D6 inhibitors, or ______________ USE IN SPECIFIC POPULATIONS _______________ CYP3A4 inducers for more than 2 weeks (2.4). • Pregnancy: May cause extrapyramidal and/or withdrawal symptoms in ______________ _____________ neonates in women exposed during the third trimester of pregnancy DOSAGE FORMS AND STRENGTHS (8.1). Extended-release injectable suspension: 441 mg, 662 mg, 882 mg or 1064 mg single-dose pre-filled syringe (3) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 3/2021 FULL PRESCRIBING INFORMATION: CONTENTS* 5.12 Potential for Cognitive and Motor Impairment WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS 5.13 Body Temperature Regulation WITH DEMENTIA-RELATED PSYCHOSIS 5.14 Dysphagia 1 INDICATIONS AND USAGE 6 ADVERSE REACTIONS 2 DOSAGE AND ADMINISTRATION 6.1 Clinical Studies Experience 2.1 Recommended Dosage 6.2 Postmarketing Experience 2.2 Missed Doses 7 DRUG INTERACTIONS 2.3 Early Dosing 7.1 Drugs Having Clinically Important Interactions with 2.4 Dose Adjustments for CYP450 Considerations ARISTADA 2.5 Important Administration Instructions 7.2 Drugs Having No Clinically Important Interactions with 3 DOSAGE FORMS AND STRENGTHS ARISTADA 4 CONTRAINDICATIONS 8 USE IN SPECIFIC POPULATIONS 5 WARNINGS AND PRECAUTIONS 8.1 Pregnancy 5.1 Increased Mortality in Elderly Patients with Dementia-related 8.2 Lactation Psychosis 8.4 Pediatric Use 5.2 Cerebrovascular Adverse Reactions, Including Stroke 8.5 Geriatric Use 5.3 Potential for Dosing and Medication Errors 8.6 CYP2D6 Poor Metabolizers 5.4 Neuroleptic Malignant Syndrome 8.7 Hepatic and Renal Impairment 5.5 Tardive Dyskinesia 8.8 Other Specific Populations 5.6 Metabolic Changes 10 OVERDOSAGE 5.7 Pathological Gambling and Other Compulsive Behaviors 10.1 Human Experience 5.8 Orthostatic Hypotension 10.2 Management of Overdosage 5.9 Falls 11 DESCRIPTION 5.10 Leukopenia, Neutropenia, and Agranulocytosis 12 CLINICAL PHARMACOLOGY 5.11 Seizures 12.1 Mechanism of Action 1 12.2 Pharmacodynamics 16 HOW SUPPLIED/ STORAGE AND HANDLING 12.3 Pharmacokinetics 16.1 How Supplied 13 NONCLINICAL TOXICOLOGY 16.2 Storage 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 17 PATIENT COUNSELING INFORMATION 13.2 Animal Toxicology and/or Pharmacology 14 CLINICAL STUDIES *Sections or subsections omitted from the full prescribing information are not listed. 2 FULL PRESCRIBING INFORMATION WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ARISTADA is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1)]. 1 INDICATIONS AND USAGE ARISTADA is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14)]. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage ARISTADA is only to be administered as an intramuscular injection by a healthcare professional. For patients who have never taken aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with ARISTADA. Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability. Refer to the prescribing information of oral aripiprazole for the recommended dosage and administration of the oral formulation. There are two ways to initiate treatment with ARISTADA: • Option #1: Administer one intramuscular injection of ARISTADA INITIO 675 mg (in either the deltoid or gluteal muscle) and one dose of oral aripiprazole 30 mg in conjunction with the first ARISTADA injection. o The first ARISTADA injection may be administered on the same day as ARISTADA INITIO or up to 10 days thereafter. See the ARISTADA INITIO prescribing information for additional information regarding administration of ARISTADA INITIO. o Avoid injecting both ARISTADA INITIO and ARISTADA concomitantly into the same deltoid or gluteal muscle. • Option #2: Administer 21 consecutive days of oral aripiprazole in conjunction with the first ARISTADA injection. Depending on individual patient’s needs, treatment with ARISTADA can be initiated at a dose of 441 mg, 662 mg or 882 mg administered monthly, 882 mg administered every 6 weeks or 1064 mg administered every 2 months. The 441 mg, 662 mg, 882 mg and 1064 mg doses correspond to 300 mg, 450 mg, 600 mg and 724 mg of aripiprazole, respectively [see Clinical Pharmacology (12.3)]. 3 Table 1: ARISTADA Dosing Frequency and Site of Injection Dose Dosing Frequency Site of Intramuscular Injection 441 mg Monthly Deltoid or Gluteal 662 mg Monthly Gluteal 882 mg Monthly or every 6 weeks Gluteal 1064 mg Every 2 months Gluteal Use the following ARISTADA doses for patients who are stabilized on oral aripiprazole, as shown in Table 2. Table 2: ARISTADA Doses Based on Oral Aripiprazole Total Daily Dose Oral Aripiprazole Dose Intramuscular ARISTADA Dose 10 mg per day 441 mg every month 662 mg every month 15 mg per day 882 mg every 6 weeks 1064 mg every 2 months 20 mg or higher per day 882 mg every month In conjunction with the first ARISTADA injection, administer a single injection of ARISTADA INITIO and one dose of oral aripiprazole 30 mg, or continue treatment with oral aripiprazole for 21 consecutive days [see Recommended Dosage (2.1)]. Adjust the ARISTADA dose as needed. When making dose and dosing interval adjustments, consider the pharmacokinetics and prolonged-release characteristics of ARISTADA [see Clinical Pharmacology (12.3)]. 2.2 Missed Doses When a dose of ARISTADA is missed, administer the next injection of ARISTADA as soon as possible. Depending on the time elapsed since the last ARISTADA injection, supplement the next ARISTADA injection as recommended in Table 3 below. 4 Table 3: Recommendation for Concomitant Supplementation
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